BEUDAMED
    FDA Registration Active 🇨🇳 China

    Infant Heel Warmer, with Disc

    Reg #: 3008955719 · FEI: 3008955719 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd
    Registration Number
    3008955719
    FEI Number
    3008955719
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Glasses Industrial Park, Danfu Road,
    City
    Danyang Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150627

    Owner / Operator

    Firm Name
    Rapid Aid Corp.
    Operator Number
    10028086
    Address
    4120A Sladeview Crescent
    City
    Mississauga
    State
    Ontario
    Postal Code
    L5L5Z3
    Country
    CA

    US Agent

    Business Name
    Mandell Horwitz Consultants LLC
    Contact Name
    Diane Horwitz
    Address
    5 Lake Como Ct
    City
    Greenville
    State
    SC
    ZIP
    29609
    Country
    US
    Email
    [email protected]
    Phone
    703 3072921

    Products

    Device Name Product Code
    Infant Heel Warmer (Chemical Heat Pack) MPO

    Proprietary Names

    Infant Heel Warmer, with Disc

    Establishment Types

    Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device